Zephyr®

Basic Information

• Brand Name: Zephyr®
• Primary DI: 05414734501606
• Version / Model: SR
• Catalog Number: 5620
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-23
• Public Version: 5
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 6fc131f2-a52a-48da-9e4e-382e9573871d

Device Description

Pulse Generator SSIR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NVZ	Pulse generator, permanent, implantable	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47267	Single-chamber implantable pacemaker, rate-responsive	A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H758562005	HIBCC
Primary	05414734501606	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P880086	139
P880086	304
P880086	307

Device Sizes

Type	Value	Unit	Text
Total Volume	7.9	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit